K-Wires for T2 and Gamma Systems (Internal fixation wire) 의 리콜

Recall

RC-2016-RN-01469-1

Class II

2016-11-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01469-1

Through a review of packaging, stryker has identified that the seal integrity of the pouch may be compromised. more specifically, there is a potential that the sterile pouch may not be sealed at one end due to a manufacturing error. a missing seal could potentially lead to unsterile product. risk mitigating factors include that the non-conformance is obvious to the user. surgical guidelines outline inspection of the sterile barrier (seal) for sterile packed medical devices prior to use. the pouch itself shows a note: “contents sterile unless this package has been damaged or opened.” the secondary packaging is a (plastic) clear tube with silicone caps at both ends. while not validated as a sterile barrier, it does provide additional protection to the enclosed pouch package configuration. no injury or harm has been reported regarding this issue.

Customers are asked to inspect their inventory for affected products and quarantine any affected items immediately. A Stryker representative will coordinate the return of any affected product and supply unaffected ones where necessary. This action has been closed-out on 28/06/2017.